Airtraq Versus Standard Direct Laryngoscopy in the Pediatric Airway - Full Text View

Sponsored by:	IWK Health Centre
Information provided by:	IWK Health Centre
ClinicalTrials.gov Identifier:	NCT00874016

Purpose

Time to intubate, view to glottic opening and success rate are not different when Airtraq technique is used compared to standard direct laryngoscopy in children.

Condition	Intervention
Endotracheal Intubation	Device: Airtraq Device: Direct Laryngoscopy

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title:	A Comparison of the Airtraq and Standard Direct Laryngoscopy in the Pediatric Airway - A Randomized Trial.

Further study details as provided by IWK Health Centre:

Primary Outcome Measures:

Time to intubation [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percentage of glottic opening seen [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	April 2009
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Airtraq: Active Comparator Intubation with the use of the Airtraq	Device: Airtraq Intubation using Airtraq
Direct Laryngoscopy: Active Comparator Intubation using direct laryngoscopy	Device: Direct Laryngoscopy Intubation using direct laryngoscopy

Detailed Description:

50 children (age 5 years and 11 month or younger) with expected easy intubation, scheduled for elective surgery requiring endotracheal intubation are enrolled.

Eligibility

Ages Eligible for Study:	up to 6 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

elective surgery requiring endotracheal intubation

Exclusion Criteria:

predicted difficult bag-mask ventilation
predicted difficult intubation
rapid sequence induction
emergency endotracheal intubation
hemodynamic instability
emergency surgery
non-english speaking caregivers/parents

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00874016

Contacts

Contact: Arnim Vlatten, MD

(902) 470 8251

arnim.vlatten@iwk.nshealth.ca

Locations

Canada, Nova Scotia
Department of Pediatric Anesthesia, IWK Health Centre	Recruiting
Halifax, Nova Scotia, Canada, B3K 6R8
Contact: Arnim Vlatten, MD (902) 470 8251 arnim.vlatten@iwk.nshealth.ca
Principal Investigator: Arnim Vlatten, MD
Sub-Investigator: Chris Soder, MD

Sponsors and Collaborators

IWK Health Centre

Investigators

Principal Investigator:

Arnim Vlatten, MD

IWK Health Centre

More Information

Publications:

Maharaj CH, Costello JF, Harte BH, Laffey JG. Evaluation of the Airtraq and Macintosh laryngoscopes in patients at increased risk for difficult tracheal intubation. Anaesthesia. 2008 Feb;63(2):182-8.

Maharaj CH, O'Croinin D, Curley G, Harte BH, Laffey JG. A comparison of tracheal intubation using the Airtraq or the Macintosh laryngoscope in routine airway management: A randomised, controlled clinical trial. Anaesthesia. 2006 Nov;61(11):1093-9.

Responsible Party:	Department of Pediatric Anesthesia, IWK Health Centre ( Arnim Vlatten, MD )
Study ID Numbers:	Airtraq 4469
Study First Received:	April 1, 2009
Last Updated:	April 1, 2009
ClinicalTrials.gov Identifier:	NCT00874016 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by IWK Health Centre:

intubation
Airtraq
pediatric
airway

ClinicalTrials.gov processed this record on September 11, 2009